Compliance Reference | WHO TRS 961 · Annex 6
WHO GMP Blister Packaging Machine:
Compliance Guide & HIJ DPP-250 Certification
Verified compliant with WHO Technical Report Series No. 961, Annex 6 — Pharmaceutical Packaging Materials
Pharmaceutical packaging equipment must meet WHO Good Manufacturing Practice requirements to protect product quality, prevent contamination, and ensure audit readiness. This page explains exactly what WHO GMP requires for blister packaging machines — and documents how the HIJ DPP-250 meets every requirement.
✓ WHO GMP Certified Design
DQ / IQ / OQ / PQ
Full Validation Pack Included
WHO GMP TRS 961 — DPP-250 Compliance Matrix
How the HIJ DPP-250 Blister Packaging Machine Meets WHO GMP Requirements
Every requirement from WHO Technical Report Series No. 961, Annex 6 — mapped to DPP-250 design features and documentation delivered with the machine.
| WHO GMP Requirement TRS No. 961, Annex 6 |
DPP-250 Implementation | Documentation Provided |
|---|---|---|
|
Product-Contact Material 316L SS or inert equivalent required |
All forming die, sealing plate, and product guide surfaces manufactured from SS 316L. Non-metal contact parts comply with FDA food-contact standards. | Material Certificates |
|
Smooth, Cleanable Surfaces No cracks, no residue-trapping areas |
Electropolished contact surfaces, Ra ≤ 0.8 μm. All seams fully welded and polished. No blind cavities in product zones. | Surface Finish Report |
|
No Residue-Trapping Geometry Easy disassembly for cleaning required |
Open-frame design with tool-free disassembly of all product guides and format parts. Cleaning SOP and contact surface area map included. | Engineering Drawing Review |
|
DQ / IQ / OQ / PQ Qualification Full 4-stage equipment qualification |
Complete DQ/IQ/OQ/PQ validation documentation provided by HIJ. Protocol templates customized for DPP-250. Completed sample reports available for review before purchase. | Protocol Templates + Sample Reports |
|
Calibration Schedule All measuring instruments traceable |
All sensors (temperature, pressure, speed) pre-calibrated before shipment. Calibration SOP, schedule template, and next-due labeling system included. | Calibration Certificates |
|
Change Control Readiness Documented change impact assessment |
HMI parameter lock with password-protected access levels. Recipe management system stores up to 100 product programs. All parameter changes logged automatically. | SOPs Provided |
|
Audit Trail & Data Integrity ALCOA+ compliant electronic records |
Siemens PLC with electronic batch record system. Time-stamped, operator-attributed audit trail. 21 CFR Part 11 compliant audit trail module available. | Software Validation Summary |
|
Preventive Maintenance Documented PM procedures required |
52-week preventive maintenance schedule included in machine manual. Spare parts list with recommended stock levels. Remote diagnostic support via Siemens TIA Portal. | PM Checklist Included |
Need the complete compliance documentation package?
Material certificates · IQ/OQ/PQ protocols · Calibration records · CE Declaration · Cleaning SOP
WHO GMP Blister Packaging Equipment: 6 Requirements Explained
The following breakdown maps each WHO GMP requirement directly to the HIJ DPP-250 pharma blister packaging machine — providing quality teams with the technical evidence needed for audit preparation.
1
Construction Materials
WHO TRS 961 · Annex 6 · Section 3WHO GMP TRS 961 states that packaging materials and equipment surfaces in contact with pharmaceutical products must not alter the product's identity, strength, quality, or purity. All product-contact materials must be non-reactive, non-additive, and non-absorptive under process conditions.
For blister packaging machines, this requirement applies to:
- Forming die cavities — direct contact with unpackaged tablets and capsules during cavity-filling
- Product hoppers and feed tracks — continuous product contact throughout the feeding cycle
- Sealing plate surfaces — indirect contact via thermal conduction during heat-sealing
DPP-250 Compliance
All product-contact components on the DPP-250 are manufactured from stainless steel 316L. Non-metal contact components — including product guides and suction cups — use FDA-compliant, inert materials with documented supplier declarations. SS 316L mill certificates and FDA material compliance statements are included with every machine delivery.
2
Cleaning Validation Readiness
WHO TRS 961 · Annex 6 · Section 5WHO GMP requires that equipment "can be cleaned to a validated standard." For blister packaging machines, achieving cleaning validation requires the supplier to provide structured documentation that supports the customer's own validation protocol.
A complete cleaning validation programme for a blister machine requires:
- Documented disassembly and reassembly procedure with photographic reference
- Identification and total surface area map of all product-contact surfaces
- Validated cleaning method with defined cleaning agents, contact times, and temperatures
- Rinse sampling or swab sampling locations with acceptance criteria
DPP-250 Compliance
HIJ provides a complete cleaning procedure SOP, a product-contact surface area map, and a step-by-step disassembly guide for the DPP-250. All format parts (forming die, sealing plate, feed tracks) are designed for tool-free removal, reducing cleaning time and supporting swab sampling at defined locations. This documentation package directly supports customers' own cleaning validation submissions.
3
Equipment Qualification (DQ / IQ / OQ / PQ)
WHO Annex 15 · ICH Q10 · GAMP 5WHO GMP Annex 15 (Qualification and Validation) requires that all new pharmaceutical equipment be formally qualified before use in production. The DPP-250 pharma blister packaging machine follows a four-stage qualification process:
DQ
Design Qualification
Confirms the DPP-250 design meets your User Requirement Specification (URS) before manufacturing begins.
- HIJ reviews customer URS document
- Written DQ report issued confirming each URS clause
- Deviations identified and resolved pre-production
IQ
Installation Qualification
Confirms correct installation at your facility. Conducted on-site by HIJ commissioning engineer.
- Utility connections (compressed air, electrical supply)
- Machine leveling and anchoring verification
- All components present and undamaged
- Software version and configuration documented
OQ
Operational Qualification
Confirms the machine operates within all specified parameters across its full operating range.
- Forming and sealing temperature range tests
- Speed range and indexing verification
- Alarm and interlock function tests
- HMI and data recording function tests
- 21 CFR Part 11 audit trail verification
PQ
Performance Qualification
Demonstrates consistent production performance with your actual pharmaceutical product.
- Minimum 3 consecutive production batches
- Blister seal integrity testing (dye penetration / vacuum)
- Visual inspection defect rate measurement
- Weight consistency data and batch record review
DPP-250 Documentation
HIJ provides DQ/IQ/OQ/PQ protocol templates customised to the DPP-250, along with completed sample reports available for customer review before purchase commitment. See the full DQ/IQ/OQ/PQ validation documentation package for the DPP-250.
4
Calibration and Instrumentation
WHO TRS 961 · GMP Chapter 3WHO GMP requires all measuring instruments to be:
- Calibrated against traceable national or international standards
- Included within a documented calibration schedule with defined intervals
- Labeled with current calibration status and next due date
Critical instruments on the DPP-250 subject to calibration requirements:
| Instrument | Location on DPP-250 | Calibration Frequency |
|---|---|---|
| Temperature sensor (forming) | Forming heater plate | Every 6 months |
| Temperature sensor (sealing) | Sealing station | Every 6 months |
| Pressure gauge (compressed air) | Air supply inlet manifold | Every 12 months |
| Speed encoder | Main drive system | Every 12 months |
| HMI real-time clock (21 CFR Part 11) | Control panel | Every 6 months |
DPP-250 Compliance
HIJ provides pre-shipment calibration certificates for all instruments listed above, traceable to national standards. A calibration SOP and annual calibration schedule template are included in the machine documentation package, ready for integration into the customer's quality system.
5
Environmental and Utility Compatibility
WHO TRS 961 · ISO 14644 · GMP Annex 1WHO GMP pharmaceutical packaging areas are classified environments — typically ISO 8 (Grade D) or higher. Blister packaging machines installed in these areas must not compromise the controlled environment. Specifically, equipment must:
- Not generate excessive particulates during normal operation
- Be compatible with HVAC-controlled temperature and humidity requirements
- Not introduce contamination risk from lubricants, hydraulic fluids, or worn components
DPP-250 Compliance
- Food-grade lubricants used in all gearboxes — no contamination risk to pharmaceutical environment
- Enclosed drive system minimises particle generation from mechanical components
- No hydraulic fluid systems — all actuation is pneumatic, eliminating hydraulic contamination risk
- Stainless steel external panels — smooth, non-shedding surfaces compatible with classified area wipe-down procedures
6
Data Integrity and Electronic Records
WHO TRS 996 Annex 5 · 21 CFR Part 11 · ALCOA+WHO's data integrity guidance (Technical Report Series No. 996, Annex 5, 2016) requires that all GMP records — including equipment-generated data — satisfy the ALCOA+ framework. For electronically controlled machinery, this means the control system must produce records that are:
A
Attributable
Who performed each action, and when
L
Legible
Permanent and readable throughout retention period
C
Contemporaneous
Recorded at the time the activity occurred
O
Original
First capture of data, not transcribed
A
Accurate
True reflection of the activity performed
+
Plus
Complete · Consistent · Enduring · Available
DPP-250 Data Integrity Features
- Siemens S7 PLC with secure parameter storage — industry-standard, auditor-recognised control platform
- Operator login required for all parameter changes — satisfies Attributable requirement
- Automatic time-stamped record of all parameter changes — satisfies Contemporaneous requirement
- Non-editable alarm history log — original records cannot be altered or deleted
- Batch production reports exportable in PDF and CSV — available for QA review and regulatory submission
- 21 CFR Part 11 compliant audit trail available as standard or optional module — for FDA-regulated and dual-compliance markets
Request the Complete DPP-250 Validation Documentation Package
DQ/IQ/OQ/PQ protocols · SS 316L material certificates · Calibration certificates ·
Cleaning SOP · 21 CFR Part 11 summary.
Questions? Email
sales@hijpackingmachine.com
or WhatsApp +86 13868822120.
Compliance Q&A
Frequently Asked Questions:
Frequently Asked Questions:
WHO GMP Blister Packaging Machines
Answers for quality assurance managers, validation engineers, and procurement teams evaluating GMP-compliant blister packaging equipment.
WHO GMP is a manufacturing practice standard, not a product certification issued to individual machines. The DPP-250 is designed and manufactured in compliance with WHO GMP Technical Report Series No. 961 (packaging equipment requirements) and WHO TRS 996 (data integrity). HIJ provides complete DQ/IQ/OQ/PQ qualification documentation to support customers' own GMP certification and regulatory inspections.
Contact sales@hijpackingmachine.com for the full compliance documentation package.
HIJ provides the following documents with every DPP-250 delivery:
(1) Design Qualification report confirming URS compliance — (2) IQ/OQ/PQ protocol templates with completed sample data — (3) SS 316L material certificates for all product-contact surfaces — (4) Pre-shipment calibration certificates for all instruments — (5) Cleaning procedure SOP and contact surface area map — (6) Preventive maintenance schedule — (7) FAT (Factory Acceptance Test) report.
Additional documents are available upon request.
The DPP-250 is currently installed and operating in WHO pre-qualified manufacturing facilities. The machine's documentation package is specifically designed to support WHO PQ inspections.
HIJ recommends customers share their specific inspection timeline with our team so documentation can be prepared accordingly. Email sales@hijpackingmachine.com with your WHO PQ timeline.
Yes. The DPP-250 is designed to comply with both WHO GMP (TRS 961) and US cGMP (21 CFR Parts 210 and 211). For FDA-regulated markets, the optional 21 CFR Part 11 audit trail module is available.
This module provides a secure, time-stamped electronic record of all operator actions and parameter changes, satisfying FDA data integrity requirements.
The qualification timeline depends on customer protocols and production schedule. Typical timeline after machine installation:
DQ review — 1 week (pre-delivery) · IQ execution — 2–3 days on-site with HIJ engineer · OQ execution — 3–5 days with HIJ engineer support · PQ execution — 2–4 weeks (3 production batches).
HIJ's commissioning engineer supports IQ and OQ on-site. Total machine qualification typically completes within 6–8 weeks of installation.
They address different requirements. CE marking (Machinery Directive 2006/42/EC) certifies machine safety for operators — required for EU market access. WHO GMP compliance addresses pharmaceutical product quality and contamination prevention — required by health authorities worldwide.
The HIJ DPP-250 carries both: CE marking for operator safety compliance and WHO GMP-aligned design with full qualification documentation for pharmaceutical regulatory compliance. For pharmaceutical use, both are necessary.
Yes. HIJ provides on-site engineering support for IQ/OQ execution and can arrange for a qualified engineer to be present during regulatory inspections of the DPP-250. Support is available in India, Southeast Asia, Africa, the Middle East, and other regions.
Contact sales@hijpackingmachine.com to discuss your audit timeline and location.
Still have compliance questions?
Request the full DPP-250 DQ/IQ/OQ/PQ validation documentation — or speak directly with our GMP engineering team.
Request WHO GMP Compliance Documentation
for the DPP-250
HIJ provides a complete compliance documentation package for the DPP-250 blister packaging machine. Quality assurance teams receive everything needed for GMP qualification, regulatory submission, and audit preparation.
Documentation Package Includes
- DQ/IQ/OQ/PQ protocol templates (DPP-250 specific)
- SS 316L material certificates for all product-contact surfaces
- Calibration certificates (pre-shipment, all instruments)
- CE Declaration of Conformity (Machinery Directive 2006/42/EC)
- WHO GMP compliance statement (TRS 961 Annex 6)
- Cleaning procedure SOP & contact surface area map
- 21 CFR Part 11 compliance summary (if applicable)
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About HIJ Machinery
HIJ Machinery (Wenzhou) manufactures pharmaceutical blister packaging machines compliant with WHO GMP Technical Report Series No. 961, 21 CFR Parts 210/211, and CE Machinery Directive 2006/42/EC. The DPP-250 blister packaging machine includes complete DQ/IQ/OQ/PQ validation documentation. Founder Forester Xiang brings 20+ years of pharmaceutical machinery expertise across 100+ facilities in 30+ countries.
Website: hijpackingmachine.com |
Contact: sales@hijpackingmachine.com
Compliance Standards
Specialization: Pharmaceutical packaging machinery, WHO GMP and cGMP compliant, CE certified.
Standards: WHO GMP TRS 961 Annex 6 · 21 CFR Parts 210 & 211 · 21 CFR Part 11 · EU GMP EudraLex Vol. 4 · CE Machinery Directive 2006/42/EC · ICH Q10 · GAMP 5
Location: Wenzhou, Zhejiang, China | Global on-site support: 30+ countries